Successful commercialization of medical technologies requires manufacturers to obtain regulatory approval and reimbursement for those technologies. This course gives an overview of the regulatory and payer environment in the U.S. and abroad, and introduces methods for health technology assessment (HTA) and comparative effectiveness research (CER)/value assessment that are commonly used. A framework is presented to identify factors that are relevant to the value proposition and adoption of new medical devices, and to the management of those factors early in the design and development phases.

Lectures and case studies. Guest speakers from government (FDA) and industry. Students investigate real-world diagnostic and therapeutic technologies in course projects. See course syllabus for additional details.

This course is listed in and offered by the Management Science & Engineering Department, and is part of the broader curriculum of Stanford Biodesign courses. It is a part of the SCPD Biomedical Engineering: Imaging, Devices and Systems Certificate Program; Product Creation and Innovative Manufacturing Certificate Program, and the MS&E Certificate Program.

Target Audience:

This course is open to students of all levels and majors that are interested in medical technology and its commercialization. No prerequisites are required. Limited enrollment.

Attendance:

Attendance of all classes is required if the course is taken for credit. Because the teaching of the content benefits from discussion, active class participation is desired. The course can be taken for 1 unit (attendance only, CR/NC - enroll in MS&E 256A) or 3 units (class and project, CR/NC or Letter Grade - enroll in MS&E 256).